速克感冒胶囊质量标准的建立

Study on the quality standard of SUKEGANMAO capsule

【目的】建立速克感冒胶囊的质量标准。【方法】采用薄层鉴别法（thin layer chromatography, TLC ）对其处方组成药味野菊花和马来酸氯苯：耶敏进行定性分析；采用高效液相色谱法（highperformanceliquidchromatography，HPLC）测定速克感冒胶囊中阿司匹林的含量。色谱柱为C18（250mm×4．6mm，5um），甲醇-0．03mol／L磷酸二氢钾（35：65）为流动相，检测波长276nm，流速1．0ml／min，进样量为10山。【结果】TLC鉴别分离度好，阴性对照无干扰；阿司匹林在进样量为1．202～12．020lag范围内具有良好的线性关系，平均回收率为99．68％，RSD为0．30％（n=9）。【结论】本方法准确、灵敏度高、重现性好，适于速克感冒胶囊的质量控制。

[Objective] To establish the quality standard for SUKEGANMAO capsule. [Methods] Chrysanthemum indicum L and Chlorphenamine maleate were identified by TLC. HPLC quantitative analysis was carried out on a C18 column（250 mm x 4.6 mm, 5um） with methanol-0.03 mol/L potassium dihydrogen phosphate solution （35：65）,the flow rate was 1.0 ml/min, the detective wavelength was set at 276 nm. The injection volume was 10μl. [Results] The TLC spots were clear and separated well without interference of negative sample. The linear rang of aspirin was 1.202-12.020 μg with average rate of recovery 99.68% （ RSD=0.30%, n = 9）. [ Conclusion ] This method is proved to be simple and reliable and can be used for the quality control of SUKEGANMAO capsule.